BLEOMYCIN for Cutaneous or subcutaneous malignancy

Inclusion criteria

• {"criterion_text":"- 1.\tTrial subject > 18 years.\n- Signed informed consent.\n- Trial subject must be able to understand the participant information.\n- Histologically verified cutaneous or subcutaneous, primary or secondary cancer of any histology.\n- Life expectancy > 3 months.\n- Trial subject can undergo simultaneous medical treatment (endocrine therapy, chemotherapy, immunotherapy, etc.) at any point during the study.\n- Trial subject may have received ECT treatment previously if selected tumours have not received ECT or if a minimum of 3 months after ECT treatment have passed.\n- Trial subject can undergo radiation therapy, provided that the treatment field does not involve the area intended to treat. If the trial subject has received radiation therapy in the area intended to treat, a minimum of 3 months should have passed.\n- A creatinine level within normal upper limit. If creatinine is above normal upper limit the subject needs to have a creatinine clearance > 50 ml/min.\n- Both men and women who are sexually active must use safe contraception. This includes the use of intrauterine device (IUD), oral contraceptives, male or female condom, vasectomy or female sterilization."}

Exclusion criteria

• {"criterion_text":"- Pregnancy or lactation. All fertile women will have to deliver a negative pregnancy test before ECT treatment.\n- Allergy or hypersensitivity to bleomycin.\n- Acute lung infection.\n- Severely impaired lung function or any lung condition the investigator deems severe.\n- Any other caution, clinical disease or previous treatments that make the investigator deem the trial subject unfit.\n- The cumulative bleomycin dose must not exceed the by the drug manufacturer recommended maximum dose."}

Primary endpoints

• {"endpoint_text":"- The primary endpoint of this study is to evaluate the clinical overall response rate of ECT treatment of cutaneous malignancies after three months.","definition_or_measurement_approach":"Clinical overall response rate of ECT treatment assessed after three months (as stated: evaluation of clinical overall response rate after three months)."}

Secondary endpoints

• {"endpoint_text":"- Treatment response for normal dose group, reduced dose group, and for all treated tumours at optional time points using RECIST criteria, digital photography and ruler.","definition_or_measurement_approach":"Treatment response assessed at optional time points using RECIST criteria, digital photography and ruler."}
• {"endpoint_text":"- Aesthetic outcome for normal dose group, reduced dose group and for all tumours after the time periods 2 to 6 months and 6 to 12 months, using the Vancouver Scar Scale and Patient and Observer Scar Assessment Scale (POSAS).","definition_or_measurement_approach":"Aesthetic outcome assessed at 2–6 months and 6–12 months using Vancouver Scar Scale and POSAS."}
• {"endpoint_text":"- Complete and partial remissions for all patients treated (patient level), i.e. number of patients experiencing objective responses on at least one treated tumour.","definition_or_measurement_approach":"Count of patients with complete or partial remission (objective responses on at least one treated tumour)."}
• {"endpoint_text":"- Biopsy after 12 months (optional) for histological examination of malignancy presence (HE stain, and staining for specific tumour markers can be included).","definition_or_measurement_approach":"Optional biopsy at 12 months with histological examination (HE stain and possible tumour marker staining)."}
• {"endpoint_text":"- All-cause mortality and cancer related mortality within 12 months.","definition_or_measurement_approach":"All-cause and cancer-related mortality recorded within 12 months."}
• {"endpoint_text":"- Quality of life before treatment and at approximately 3 months. a.\tEORTC questionnaire C30 (all patients) – data from normal dose group, reduced dose group, and for the whole population will be registered and compared. b.\tQualitative interviews (optional, subset of patients) – descriptive list of symptoms from normal dose group, reduced dose group, and for the whole population will be registered and compared.","definition_or_measurement_approach":"Quality of life assessed using EORTC QLQ-C30 before treatment and at ~3 months; optional qualitative interviews for a subset."}
• {"endpoint_text":"- Relation between tumour histology Response rates and response duration according to tumour histology – data from normal dose group, reduced dose group, and for the study population will be registered and compared.","definition_or_measurement_approach":"Response rates and response duration analysed by tumour histology across dosing groups."}
• {"endpoint_text":"- Response rates and response duration in tumours according to size (≤3cm or > 3cm) – data from normal dose group, reduced dose group, and for the whole population will be registered and compared.","definition_or_measurement_approach":"Response rates and duration stratified by tumour size (≤3 cm vs >3 cm) across dosing groups."}
• {"endpoint_text":"- Side effects according to CTCAE according to treatment dose – data from normal dose group, reduced dose group, and for the whole population will be registered and compared.","definition_or_measurement_approach":"Adverse events graded per CTCAE and compared by treatment dose groups."}
• {"endpoint_text":"- The emergence of pain due to cutaneous malignancies, assessed using Numeric Rating Scale (NRS).","definition_or_measurement_approach":"Pain assessed using Numeric Rating Scale (NRS)."}
• {"endpoint_text":"- Pharmacokinetics (blood samples at 0, 5, 10, 20, 30 and 40 minutes after bleomycin infusion) will be analysed depending on age, treatment dose, Body Surface Area (BSA), kidney function (eGFR panel).","definition_or_measurement_approach":"PK blood sampling at 0, 5, 10, 20, 30 and 40 minutes post-infusion; analyses stratified by age, dose, BSA, kidney function."}
• {"endpoint_text":"- Bleomycin concentration in tumour (UHPLC-ESI-MS), including concentration vs time.","definition_or_measurement_approach":"Tumour bleomycin concentration measured by UHPLC-ESI-MS including concentration vs time profiling."}
• {"endpoint_text":"- In order to examine if the faction of tumour cells in tumour biopsies matters for the bleomycin concentration at measured time points (0,2, 4, 6, 8 minutes after bleomycin infusion) the concentration of bleomycin in tumour tissue from the normal dose group, the reduced dose group, and for the whole population will be analysed and compared","definition_or_measurement_approach":"Tumour tissue bleomycin concentration measured at 0, 2, 4, 6, 8 minutes post-infusion and compared across dosing groups and by tumour cell fraction."}

Denmark

Earliest CTIS Part Ii Submission Date

20-06-2024

Latest Decision Or Authorization Date

20-03-2026

Processing Time Days

638

Number Of Sites

2

Number Of Participants

55

Primary sponsor

Full Name

Region Sjaelland

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Denmark","full_name":"Frederiksberg Hospital","duties_or_roles":"sponsorDuties code: 1","organisation_type":"Hospital/Clinic/Other health care facility"}